What is Ultibro breezhaler used for?

This inhaler is used regularly on a daily basis to help keep the airways open.

How does Ultibro breezhaler work?

Ultibro breezhaler contains the two active ingredients, indacaterol and glycopyrronium. These medicines work in two different ways to open the airways and make it easier to breathe.

Indacaterol is a type of medicine called a long-acting beta 2 agonist or bronchodilator. It works by acting on receptors in the lungs called beta 2 receptors. It stimulates these receptors and causes the muscles in the airways to relax. This allows the airways to open.

In chronic obstructive lung diseases (COPD), such as chronic bronchitis or emphysema, the airways are narrowed, and this makes breathing difficult. By opening the airways, indacaterol makes it easier to breathe.

Indacaterol doesn't open the airways as quickly as short-acting beta 2 agonists such as salbutamol or terbutaline, however, it does keep the airways open for much longer. The effects of indacaterol last for about 24 hours, whereas those of salbutamol or terbutaline last for about 3 to 5 hours. This means indacaterol can be used to help keep the airways open in people with chronic obstructive pulmonary disease.

Glycopyrronium bromide is a type of medicine known as an antimuscarinic or anticholinergic bronchodilator. It works by blocking receptors called muscarinic receptors that are found on the muscle surrounding the airways. A natural chemical called acetylcholine normally acts on these receptors, causing the muscle in the airways to contract and the airways to narrow. By blocking these receptors, glycopyrronium stops the action of acetylcholine on them. This allows the muscle around the airways to relax and the airways to open. This makes it easier for people with COPD to breathe.

Indacaterol and glycopyrronium are inhaled into the lungs using an inhaler device called a breezhaler inhaler. This allows the medicines to act directly in the lungs. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if the medicines were taken by mouth.

How do I use Ultibro breezhaler?

Ultibro breezhaler comes with capsules that contain the medicine in powder form. These capsules are put in the chamber in the inhaler. You then use the inhaler to pierce the capsule and breathe in the powder. Do not swallow the capsules.

It is important to follow the instructions provided with the breezhaler carefully, and talk to your doctor, pharmacist or nurse if you are unsure how to use the device, or have any problems using it.

The usual dose of Ultibro is one capsule to be inhaled once daily. The daily dose should be taken at the same time each day. The effect of the medicine lasts for 24 hours.

If you forget to take your dose at your usual time, then take it as soon as you remember that day. Then take your next dose at your usual time the following day. If you forget to take a dose for a whole day then just leave out the missed dose. Do not take more than one dose in a day to make up for a missed dose.

You should not suddenly stop using this inhaler, even if you don't currently have any symptoms, unless your doctor tells you otherwise. This is because stopping treatment is likely to make your symptoms come back.

Do not exceed the recommended dose of this medicine.

Each Ultibro breezhaler should be disposed of after 30 days of use, preferably by returning it to your pharmacy.

Important information about Ultibro breezhaler

Do not swallow the capsules. Make sure you follow the instructions provided with your Ultibro breezhaler. These tell you how to put a capsule in the inhaler, how to pierce the capsule with the inhaler and how to breathe in the medicine using the inhaler, as well as how to clean the inhaler and various other pieces of information. Do not use Ultibro breezhaler capsules with any other inhaler, and do not use Ultibro breezhaler to take any other capsule medicine.

Ultibro should not be used to relieve an attack of breathing difficulty. Instead, it should be used regularly each day to keep the airways open and help prevent breathing difficulties. You should keep your reliever inhaler (short-acting bronchodilator, eg salbutamol or terbutaline ) with you at all times in case you need to relieve wheezing or shortness of breath.

If this inhaler does not seem to prevent wheezing or chest tightness as well as usual, or for as long as usual, or if you find you need to use your reliever inhaler (eg salbutamol or terbutaline) more often than normal, you should consult your doctor as soon as possible. It may be that your COPD is getting worse and your doctor might need to give you another medicine.

Inhalers may cause an unexpected increase in wheezing (paradoxical bronchospasm) straight after using them. If this happens, stop using the inhaler immediately and consult your doctor. The medicine should be stopped and an alternative treatment found.

This medicine can cause a dry mouth, which may increase the risk of tooth decay with long-term use of the medicine. It is therefore important to practise good oral hygiene and visit your dentist regularly for check-ups.

People with severe COPD should have regular blood tests to monitor the amount of potassium in their blood. This is because low oxygen levels in the blood (hypoxia) and various COPD medicines, including this one, can lower blood potassium levels.

Ultibro breezhaler should not be used by

The capsules used in Ultibro breezhaler contain lactose. This medicine should not be used by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the unborn baby. Seek medical advice from your doctor.

It is not known if indacaterol and glycopyrronium pass into breast milk after inhalation. You should seek medical advice from your doctor before breastfeeding while using this medicine.

Possible side effects of Ultibro breezhaler

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Obstruction to the outflow of urine from the bladder and difficulty passing urine (urinary retention).

Swelling of the ankles and feet (peripheral oedema).

Feeling weak or fatigued.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Ultibro breezhaler affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

This inhaler should not be used in conjunction with any other medicines that contain long-acting beta-agonists, for example salmeterol or formoterol.

This medicine should not usually be used in combination with beta-blocker medicines, such as atenolol, propranolol or timolol. This is because beta-blockers have an opposite action to this medicine and cause the airways to narrow. This can result in breathing difficulties for people with COPD. This problem has sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.

Indacaterol can potentially cause a decrease in the levels of potassium in the blood (hypokalaemia), which may result in adverse effects. This effect can be increased by the following medicines, which can also lower potassium in the blood:

xanthine derivates, such as theophylline or aminophylline

corticosteroids, such as beclometasone and prednisolone

other beta 2 agonists, such as salbutamol

diuretics, such as bendroflumethiazide and furosemide.

This is why people with severe COPD, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.

This medicine has not been studied in combination with other anticholinergic medicines such as those below, and these are therefore not recommended while you are using this medicine:

aclidinium

ipratropium

oxitropium

tiotropium.

If you experience a dry mouth as a side effect of this medicine you may find that medicines that are designed to dissolve and be absorbed from under the tongue, eg sublingual glyceryl trinitrate (GTN) tablets for angina, become less effective. This is because the tablets do not dissolve properly in a dry mouth. To resolve this, drink a mouthful of water before taking sublingual tablets.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain both indacaterol and glycopyrronium as the active ingredients.

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